Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder
Not Applicable
Completed
- Conditions
- Chronic Posttraumatic Stress Disorder
- Interventions
- Registration Number
- NCT01024140
- Lead Sponsor
- Northern California Institute of Research and Education
- Brief Summary
The primary aim of this pilot study is to test the efficacy of the selective serotonin re-uptake inhibitor, Escitalopram, in the treatment of posttraumatic stress disorder (PTSD) in an open clinical trial.
A secondary aim is to determine whether treatment with escitalopram increases plasma allopregnanolone levels in patients with PTSD and if increases in allopregnanolone levels are correlated with treatment efficacy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
Inclusion Criteria
- Current DSM-IV TR PTSD and a score > 40 on the CAPS, as a result of a traumatic event that occurred at least 6 months prior to evaluation.
Exclusion Criteria
- Lifetime history of bipolar or any psychiatric disorder with psychotic features.
- Prominent suicidal or homicidal ideation.
- History of alcohol abuse/dependence within the past 3 months.
- History of drug abuse/dependence within the past 6 months.
- Subjects who plan to start a new form of psychotherapy during the protocol.
- History of sleep apnea, neurological disorder and/or current systemic illness affecting central nervous system function.
- History of myocardial infarction in the past year.
- Subjects on antipsychotic medications, systemic steroid medication, antidepressants, mood stabilizers, antianxiety medication, or benzodiazepines within the past 2 weeks.
- Use of Citalopram or Escitalopram within the past 6 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Escitalopram Escitalopram Flexible dose (5-20mg/day) of escitalopram monotherapy.
- Primary Outcome Measures
Name Time Method The Clinician Administered PTSD Scale Administered at baseline (prior to treatment) and week 12
- Secondary Outcome Measures
Name Time Method Social Adjustment Scale Initial, Mid-Trial and Final Assessments Quality of Life Inventory Initial, Mid-Trial and Final Assessments PTSD Checklist Each Visit: Week 0, 2, 4, 6, 8, & 12 Beck Depression Inventory Each Visit: Week 0, 2, 4, 6, 8, & 12 Profile of Mood State Each Visit: Week 0, 2, 4, 6, 8, & 12